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A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer, Lung Cancer

Thank you

Trial Information

A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC


Inclusion Criteria:



Lung cancer patients who answer true to the following statements are eligible to join this
clinical study.

- I have a confirmed diagnosis of locally advanced or metastatic non small cell lung
cancer (Stage IIIb - IV)

- I have had 1st line anti-cancer therapy. Previous treatment with Avastin
(bevacizumab) in first line NSCLC is allowed.

Exclusion Criteria:

Lung cancer patients who answer true to the following are NOT eligible to join this
clinical study.

- I do not have non small cell lung cancer (NSCLC)

- I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel
is acceptable.

- I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd
line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744),
Alimta (pemetrexed) are not eligible)

- I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib,
sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st
line non small cell lung cancer is permitted.

- I have a history of uncontrolled irregular heartbeat

- I have a history of high blood pressure which has not been controlled with medication
If you are unsure of the meaning of the inclusion and exclusion criteria above,
please contact the call center number for help.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS) in the Overall Population

Outcome Description:

Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.

Outcome Time Frame:

RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months

Safety Issue:

No

Principal Investigator

AstraZeneca Zactima Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4200C00032

NCT ID:

NCT00312377

Start Date:

May 2006

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Non-small cell lung cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteHays, Kansas  
Research SiteAshland, Kentucky  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteLas Vegas, Nevada  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteCharleston, South Carolina  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia